510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K904645Substantially Equivalent

Hall Transceervical Safe Access Cannula(tm)

Hall Medical Laboratories, Shawnee KS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904645 is the FDA 510(k) clearance record for HALL TRANSCEERVICAL SAFE ACCESS CANNULA(TM), a class II device, cleared for Hall Medical Laboratories on under FDA product code HET (Laparoscope, Gynecologic (And Accessories)). FDA records list 2 510(k) clearances for Hall Medical Laboratories, from to . As of , FDA records show no recalls naming K904645.

Clearance record

Decision date
Received
(138 days to decision)
Product code
HET Laparoscope, Gynecologic (And Accessories)
Regulation
21 CFR 884.1720
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Hall Medical Laboratories 5751 Richards Cir., Shawnee KS
Third party review
No

Clearances, product code HET

Trailing 12 months

FDA records hold no clearances under product code HET in the trailing twelve months.

FDA records show no clearances under product code HET in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HET, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260